Label: FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E solution
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Contains inactivated NDC Code(s)
NDC Code(s): 50865-207-03, 50865-207-09, 50865-207-17, 50865-207-24, view more50865-207-31, 50865-207-41, 50865-207-78, 50865-207-91 - Packager: Kutol Products Company, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 16, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
For external use only.
Avoid contact with eyes. If contact occurs, flush with water.
Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.
Keep out of reach of children. If swallowed, contact a physician or poison control center.
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.
Avoid contact with eyes. If contact occurs, flush with water.
Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.
Keep out of reach of children. If swallowed, contact a physician or poison control center.
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E
foaming instant hand sanitizer with aloe and vitamin e solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50865-207 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETATE SODIUM (UNII: MP1J8420LU) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50865-207-03 208175 mL in 1 DRUM; Type 0: Not a Combination Product 05/31/2016 2 NDC:50865-207-09 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/31/2016 3 NDC:50865-207-17 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/31/2016 4 NDC:50865-207-24 1000 mL in 1 BAG; Type 0: Not a Combination Product 05/31/2016 5 NDC:50865-207-31 1000 mL in 1 BAG; Type 0: Not a Combination Product 05/31/2016 6 NDC:50865-207-41 1000 mL in 1 BAG; Type 0: Not a Combination Product 05/31/2016 7 NDC:50865-207-78 950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/31/2016 8 NDC:50865-207-91 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/31/2016 Labeler - Kutol Products Company, Inc. (004236139) Establishment Name Address ID/FEI Business Operations Kutol Products Company, Inc. 004236139 manufacture(50865-207) , analysis(50865-207) , label(50865-207) , pack(50865-207)
